USDA Updates

Dr. Carol ClarkeResearch Staff Officer

USDA-APHIS Animal Care

2 Petitions Have Been Submitted

• PCRM: – Develop clear and more stringent requirements

for identifying and using alternatives.

• New England Anti-vivisectionist Society:– Ethologically appropriate environments for

nonhuman primates in research

WHAT HAPPENS WHEN A PETITION IS SUBMITTED TO ANIMAL CARE?

STEP #1: PETITION IS RECEIVED

• Petitions comes to the attention of Animal Care through APHIS’ Legislative and Public Affairs staff

• A work plan is created– Summarizes the petition– Outlines possible impacts– Primary and secondary contacts are identified

• Work plan is submitted to the Regulatory Analysis and Development (RAD) staff in APHIS

STEP #2: POSTING FOR PUBLIC COMMENT

• RAD prepares the petition for public comment– Creates questions relevant to the petition for the

public to provide input– Petition is published in the Federal Register and

posted for public comment on Regulations.gov– Comment period 60 days initially

• Animal Care also notifies stakeholders through the Stakeholder Registry

STEP #3 REVIEW OF COMMENTS

• Public responses are reviewed at the end of the comment period– A summary of the comments is made

• APHIS makes a decision as to whether rulemaking is warranted

Sources of Rulemaking

The impetus for rulemaking can come from many sources, including:

• Agency acting on its own initiative, • Statutory requirements, • Congressional hearings,• Court orders ,• Emergency situations, and/or• Stakeholder requests

What Governs the Rulemaking Process?

The principal requirements for rulemaking are set by the Administrative Procedure Act (APA)

The APA Rulemaking Process

• Sometimes referred to as “notice-and-comment” rulemaking

• Basic 3-step process, or procedural “floor”– Publication of proposed rule in the Federal

Register– Comment period– Publication of a final rule that responds to

comments and amends the regulations

Publication in the Federal Register

• Provides official notice of a regulation’s existence

• Establishes the Federal Register text as true copy of original signed document

• Gives regulations evidentiary status so they are admissible in court

• Shows how and why the Code of Federal Regulations would/will be amended

The Rulemaking Process

Step 1Step 2

Step 3Step 4

Step 5Step 6

Step 7

Proposed Rule Stage

Need Identified

Preliminary Analyses

Regulatory Workplan

Preparation of Proposed Rule

Clearance Process

Publication of Proposed Rule

Comment Period

Final Rule Stage

Step 1Step 2

Step 3Step 4

Step 5Comment Review

Regulatory Workplan

Preparation of Final Rule

Publication of Final Rule

Clearance Process

Final Rule Stage

• After comment period:– Agency reviews comments and prepares

response– Revises text of final rule and analyses as

appropriate• Final rule then submitted for review as with

proposed rule• Final rule published in the Federal Register– Final rules have the force and effect of law

How Long Does This Process Take?

• Time depends on:– Complexity of rule– Number and nature of comments received– Priority assigned by the Agency– The designation assigned by OMB– Trade negotiations and political issues

Internet Resources

• Regulations.gov• Federal Register:

http://www.gpoaccess.gov/fr/• e-CFR: http://ecfr.gpoaccess.gov/

Getting Back to the 2 Petitions…

• No date yet for posting of petitions

• Much too early to say whether the petitions will result in a regulatory change

• APHIS prefers non-regulatory solutions to issues of concern where possible

Importation of Live Dogs

Final rule: Docket No. APHIS–2009–0053 Effective 11/14/2014• Animal Welfare Act amended to ensure health and welfare of

imported dogs

Prohibits the importation of dogs into the US for resale unless the Secretary determines the dogs:• are in good health, • received all necessary vaccinations,• are at least 6 months of age.

Excludes importation for research and health reasons, however there is no ‘blanket pass’ for research facilities to import unvaccinated dogs in poor health and/or under 6 months of age.

Requirements for Dogs Imported for Research Under New Rule

• Importers of dogs for research must:– Complete an Animal Care import permit• Form under development

– Provide a health certificate for each animal

– Submit evidence to APHIS where applicable why requirements (6 mo. age, vaccination, good health) would interfere with an IACUC-approved protocol

Your VMO or Regional Office is available to listen!

Get updates through our stakeholder registry

https://public.govdelivery.com/accounts/USDAAPHIS/ subscriber/new

Animal Care Always Available for Guidance